ArticleClinical and translational science2015
Readability of Invasive Procedure Consent Forms.
Article in Clinical and translational science, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
35 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The Quality of Informed Consent Forms-a Systematic Review and Critical Analysis.Deutsches Arzteblatt international · 2018Pooled it
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- Informed Consent Practices in Research Involving Persons with Disorders of Consciousness.Neurocritical care · 2026Article
- Artificial intelligence meets medical rarity: evaluating ChatGPT's responses on post-orgasmic illness syndrome.International journal of impotence research · 2025Article
- Readability of Informed Consent Forms for Medical and Surgical Clinical Procedures: A Systematic Review.Clinics and practice · 2025Review
- Assessing health literacy and subsequent implementation of an animated video to enhance understanding for patients with nephrolithiasis.Current urology · 2024Article
- Assessing ChatGPT's ability to answer questions pertaining to erectile dysfunction: can our patients trust it?International journal of impotence research · 2024Article
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- Websites about, not for, adolescents? A systematic analysis of online fertility preservation information for adolescent and young adult cancer patients.Journal of cancer survivorship : research and practice · 2024Article
- Leveraging Generative Artificial Intelligence Models in Patient Education on Inferior Vena Cava Filters.Clinics and practice · 2024Article
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- Bridging the literacy gap for surgical consents: an AI-human expert collaborative approach.NPJ digital medicine · 2024Article
- Unveiling readability challenges: An extensive analysis of consent document accessibility in clinical trials.Journal of clinical and translational science · 2024Article
- Open Brain AI and language assessment.Frontiers in human neuroscience · 2024Article
- How Easy Is It to Read Websites About Schizophrenia?Cureus · 2023Article
- Large Language Model-Based Chatbot vs Surgeon-Generated Informed Consent Documentation for Common Procedures.JAMA network open · 2023Article
- Article
- Video Consent for Upper Endoscopy and Colonoscopy Improves Patient Comprehension in a Safety-net, Multi-lingual Population.Journal of immigrant and minority health · 2023Article
- Websites about, not for, adolescents? A systematic analysis of online fertility preservation information for adolescent and young adult cancer patients.Research square · 2023Article
- Talking with Patients about Surgical Trainees.The Journal of clinical ethics · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInformed consent is a pillar of ethical medicine which requires patients to fully comprehend relevant issues including the risks, benefits, and alternatives of an intervention. Given the average reading skill of US adults is at the 8th grade level, the American Medical Association (AMA) and the National Institutes of Health (NIH) recommend patient information materials should not exceed a 6th grade reading level. We hypothesized that text provided in invasive procedure consent forms would exceed recommended readability guidelines for medical information. MATERIALS AND
methodsTo test this hypothesis, we gathered procedure consent forms from all surgical inpatient hospitals in the state of Rhode Island. For each consent form, readability analysis was measured with the following measures: Flesch Reading Ease Formula, Flesch-Kincaid Grade Level, Fog Scale, SMOG Index, Coleman-Liau Index, Automated Readability Index, and Linsear Write Formula. These readability scores were used to calculate a composite Text Readability Consensus Grade Level.
resultsInvasive procedure consent forms were found to be written at an average of 15th grade level (i.e., third year of college), which is significantly higher than the average US adult reading level of 8th grade (p < 0.0001) and the AMA/NIH recommended readability guidelines for patient materials of 6th grade (p < 0.0001).
conclusionInvasive procedure consent forms have readability levels which makes comprehension difficult or impossible for many patients. Efforts to improve the readability of procedural consent forms should improve patient understanding regarding their healthcare decisions.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.